Multiple Sclerosis, Relapsing-RemittingPhase 4OPTIONSNCT03126760
Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
A Phase 4 study testing Acthar Gel in people with Multiple Sclerosis, Relapsing-Remitting, run by Mallinckrodt ARD LLC at 22 sites in United States.
Trial summary
This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Acthar Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 22 sitesUnited States
- Study dates
- 22 May 2017to 14 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- Had a relapse with onset ≤42 days prior to the Baseline Visit
- Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom
- Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids
- Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit
Who cannot join
None listed.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, 30327
University of South Florida
Bradenton, Florida, 34205
University of Buffalo
Buffalo, New York, 14215
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Texas Neurology, PA
Dallas, Texas, 75214
University of Cincinnati Physicians Company, LLC
Dayton, Ohio, 45417
Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center)
Detroit, Michigan, 97205
Advanced Neurosciences Research LLC
Fort Collins, Colorado, 80528
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
Neurology Associates, P. A.
Maitland, Florida, 32751
University of Miami - Miller School of Medicine
Miami, Florida, 33136
Consultants in Neurology LTD
Northbrook, Illinois, 60062
Stanford University Medical Center
Palo Alto, California, 94304
OSF Healthcare System Saint Francis Medical Center
Peoria, Illinois, 61603
Neurology Center of San Antonio
San Antonio, Texas, 78258
Northern Ohio Neuroscience, LLC
Sandusky, Ohio, 44870
Meridian Clinical Research LLC
Savannah, Georgia, 31405
MultiCare Neuroscience Center of WA
Tacoma, Washington, 98405
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, 32308
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of Acthar® in Subjects With Relapsing-remitting Multiple Sclerosis
This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Acthar Gel, Placebo
- Keywords
- Relapsing, Remitting Multiple Sclerosis, RRMS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar GelDrug
Also called Repository Corticotropin Injection
Acthar Gel 1 mL (80U) for subcutaneous injection
PlaceboDrug
Also called Matching Placebo
Placebo for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Acthar Gel | Experimental | Participants receive Acthar Gel under the skin once a day for 14 consecutive days Receives: Drug: Acthar Gel |
| Placebo | Placebo comparator | Participants receive Placebo under the skin once a day for 14 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.
Measured: Baseline, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start22 May 2017
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Why it stopped: Recruitment difficulties and COVID-19 logistical challenges; no safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt ARD LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126760
- Sponsor's protocol ID
- MNK14274069
- Acronym
- OPTIONS
- Status last verified
- Jun 2021
- First submitted
- 4 Apr 2017
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03126760) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of Acthar® in Subjects With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03126760
- Acronym / sponsor ID
- OPTIONS / MNK14274069
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Relapsing, Remitting Multiple Sclerosis, RRMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties and COVID-19 logistical challenges; no safety concerns
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mallinckrodt ARD LLCIndustry (pharma, biotech, devices)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 3 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acthar Gel | Experimental | Drug: Acthar GelParticipants receive Acthar Gel under the skin once a day for 14 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive Placebo under the skin once a day for 14 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- Had a relapse with onset ≤42 days prior to the Baseline Visit
- Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom
- Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids
- Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acthar GelAlso: Repository Corticotropin InjectionActhar Gel 1 mL (80U) for subcutaneous injection | Drug | Acthar Gel |
| PlaceboAlso: Matching PlaceboPlacebo for subcutaneous injection | Drug | Placebo |
Primary outcome
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
Time frame: Baseline, Day 42
The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03126760) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Team Leader study director
Mallinckrodt
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acthar Gel in people with Multiple Sclerosis, Relapsing-Remitting, run by Mallinckrodt ARD LLC at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 (time frame: Baseline, Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.